Kerja Sepenuh Masa, QC Associate (Key User) di Sanofi - Maukerja

About the job

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

Main responsibilities:

• Being representative of the site in the Business Operating Communities (BOC) related to QC digital core models, led by the global, in his/her scope and ensuring local communication.
• Executing local deployments of QC digital solutions (core model and local), in accordance with defined deployment plans and validation protocols.
• Issuing all local documentation related to QC digital solutions in scope, required to ensure their usage and maintenance in an appropriate way.
• Providing training and support of end-users on QC digital tools (in coordination with Sanofi global teams for core models).
• Maintaining and updating master data and end-user access to the QC digital tools, according to defined requirements and documentation.
• Informing his/her manager of any event related to digital systems in scope in a timely manner to ensure investigation and impact assessment are performed appropriately.
• Participating actively to any investigation, where he/she is involved, to ensure investigations and impact assessment are performed appropriately.
• Executing assigned CAPAs related to remediation plans, mitigation plans and continuous improvements.
• Support annual method review in the framework of annual product review
• Support the invalid assay trending program in the QC laboratory.
• Lead compendial compliance assessment and adherence for the QC laboratory.
• Lead periodic analytical method control trend review/ investigation and data evaluation on method performance, recommend method improvements where appropriate.
• Support the execution of qualification and maintenance operations related to QC equipment of the quality control laboratory to ensure adherence to the committed scheduled plans.
• Ensuring all QC equipment are properly qualified and maintained for their intended use.
• Contribute to the compliance of laboratory GXP asset qualification and maintenance with applicable regulatory requirements and company quality standards.
• Contribute to the proper documentation, issuance, review, and approval of qualification and maintenance deliverables, such as risk assessments, traceability matrices, protocols, reports, deviations, and summary reports.
• Investigating on a timely manner and resolving any quality control events, issues or discrepancies from his/her perimeter. Implementing remediation actions from findings and CAPAs.
• Providing support during regulatory inspections and audits by presenting equipment management and Method validation documents and records.
• Leading initiatives for continuous improvement in QC support processes related to lab equipment management.
• Writing/reviewing protocols, user acceptance test (UAT) and reports related to analytical validation/transfers and qualification activities.
• Participate in Change Control Request facilitation and management in relation to QC test methods.
• Provide technical system administrator support for QC GXP laboratory computerized systems.
• Assume role of SME for Labware LIMS and collaborate closely with global site functions to address changes
• Ensuring laboratory instruments and facilities are kept in a quality and safety status to ensure that they can be used appropriately.
• Recording all expected raw data, calculations, information, related to his/her tasks, to comply with cGMP and Data integrity requirements.
• Performing his/her tasks in accordance with cGMP and HSE requirements, and with the associated instructions, procedures, records, related to these tasks.

About you

• Bachelor’s degree in Chemistry, Pharmaceutical Science, Biotechnology, Engineering, or a related field.
• Relevant experience in pharmaceutical Quality Control or a regulated GxP laboratory environment.
• Experience with QC digital systems, LIMS, computerized systems, equipment qualification, analytical method validation, or method transfer.
• Good knowledge of cGMP, data integrity, deviation, CAPA, change control, and validation requirements.
• Strong analytical, documentation, communication, and stakeholder management skills.
• Able to work independently, support end users, deliver training, and collaborate with local and global teams.
• Fluent in written and spoken English.

Why choose us?

• Bring the miracles of science to life alongside a supportive, future-focused team.
• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including health insurance, out-patient benefits along with a range of family friendly policies such as maternity, paternity, and solo parent leaves to name a few.